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SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

ConditionsTAVI(Transcatheter Aortic Valve Implantation)Aortic Valve Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
Sponsordr Pim A.L. Tonino

About this trial

The goal of this observational study is to document which LV-guidewires are used during a TAVI (Transcatheter Aortic Valve Implantation) procedure and how their different functions perform.

A TAVI procedure is a minimally invasive treatment for aortic stenosis, where a new heart valve is inserted through a blood vessel in the groin. During this procedure, a wire (specifically, an LV-guidewire) is used to place the new heart valve. For this purpose, a regular LV-guidewire or a newer LV-guidewire with extra features, the Savvywire, can be used. All of these wires work well, are safe, and are already used in daily medical practice. Researchers will compare these LV-guidewires to see if the Savvywire adds additional value.

Patients aged 50 or older who undergo a TAVI procedure via the femoral artery (blood vessel in the groin) can participate. Participants will receive the usual care and standard follow-up, only their data will be collected and analyzed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 50 years

Accepted for transfemoral TAVI procedure by Heart team and TAVI team

Transfemoral TAVI procedure with balloon-expandable or self-expandable TAVI platform

Ability to understand and the willingness to provide written informed consent

Disqualifiers

Patients planned for a non-transfemoral TAVI procedure

Extremely horizontal aorta (aortic root angle >70 degrees)

Extreme tortuosity at the level of the iliofemoral arteries, abdominal and/or thoracic aorta

Inability to provide informed consent.

Trial population

All patients eligible for participation in this registry are aged ≥50 years old presenting with symptomatic severe aortic valve stenosis and accepted for transfemoral TAVI procedure after consultation in the Heart team and TAVI team. A pre-procedural CT scan for TAVI sizing is required as standard of care. Both balloon-expandable and self-expandable TAVI platforms are allowed. Valve-in-valve procedures and procedures in bicuspid aortic valve anatomy can be included.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: SavvyWire
Group B: Other LV-guidwire

Trial outcomes

Primary outcomes

1

Register which TAVI LV-guidewires are used in contemporary practice

Register which type of TAVI LV-guidewire is used during the TAVI procedure (SavvyWire, Safari, Confida etc).

Time frame
At enrollment
2

To register LV-aortic pressure gradients (mmHg) during each procedural step in the SavvyWire group.

With the SavvyWire, continuous hemodynamic pressure measurements can be performed during the procedure in the aorta and the left ventricle. Pressure measurements (mmHg) during the following procedural steps will be collected: baseline, pacing during predilatation, after predilatation, pacing during TAVI deployment, after TAVI deployment, after equilibration and drift check, after possibele postdilatation.

Time frame
Collected during TAVI procedure, extracted at enrollment
3

To correlate hemodynamic pressure gradient after each procedural step (predilatation, 80% TAVI deployment, postdilatation) to standard baseline CT assessment of valvular calcifications

Time frame
At enrollment
4

Performance of the SavvyWire as LV-guidewire for TAVI device placement

Based on: guidewire kink yes/no, procedural success, complications during and after TAVI procedure and after standard 3 months follow-up (vascular complication, coronary obstruction, conversion to sternotomy, pacemaker, cva, mortality)

Time frame
At enrollment + after 3 months of standard follow-up

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

dr Pim A.L. Tonino

Lead sponsor

Catharina Ziekenhuis Eindhoven

Sponsor institution

Haemonetics Corporation

Collaborator

Source ClinicalTrials.gov
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